Apparatuses for cleaning catheter ports

ABSTRACT

Methods and apparatus for cleaning a central venous catheter port are disclosed. An apparatus includes a body, a coupling configured to connect the body to the hub, a cleaning cap coupled to the body, and an actuator disposed within the body for rotating and translating the cap relative to the hub. The cleaning cap includes a cap body defining a cavity and a cleaning member disposed within the cavity, the cleaning member having threads that engage with the threads on the hub.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 120 and is acontinuation of U.S. application Ser. No. 15/512,399, entitled“APPARATUSES FOR CLEANING CATHETER PORTS” and filed Mar. 17, 2017, whichis a national stage filing under 35 U.S.C. § 371 of InternationalApplication No. PCT/US2015/051112, entitled APPARATUSES FOR CLEANINGCATHETER PORTS and filed Sep. 19, 2015. International Application No.PCT/US2015/051112 claims the benefit under 35 U.S.C. § 119(e) to U.S.provisional application Ser. No. 62/053,049, entitled APPARATUSES FORCLEANING CATHETER PORTS and filed Sep. 19, 2014, and to U.S. provisionalapplication Ser. No. 62/073,154, entitled APPARATUSES FOR CLEANINGCATHETER PORTS and filed Oct. 31, 2014. The disclosures of each of theapplications listed above are incorporated by reference herein in theirentireties.

FIELD

The disclosed embodiments are generally directed to apparatuses forcleaning a catheter port.

BACKGROUND

Catheters such as central venous catheters (“CVCs”) are placed intolarge veins of the human body (e.g., the jugular vein, the axillaryvein, or the femoral vein). Needleless CVC connectors are used forinjecting medications, administering an intravenous (“IV”) infusion, andcollecting blood samples, as they eliminate the potential for a bedsideproviders to prick themselves with a needle. Catheter-relatedbloodstream infections (“CLABSIs”) are a serious healthcare problem, andneedleless catheter (“NC”) hubs are thought to be a primary mechanism ofinfection transmission. Cleaning the NC has been shown to be animportant step in the reduction in CLABSI incidence.

SUMMARY OF INVENTION

According to one embodiment, an apparatus for cleaning a hub of acatheter is disclosed. The apparatus includes a body, a couplingconfigured to connect the body to the hub, a cleaning cap coupled to thebody, and an actuator disposed within the body for rotating andtranslating the cap relative to the hub.

According to another embodiment, a cleaning cap for cleaning aneedleless hub of a catheter is disclosed. The cap includes a cap bodydefining a cavity, and a cleaning member disposed within the cavity, thecleaning member having cleaning threads that engage with externalthreads of the hub.

According to another embodiment, an apparatus for cleaning a hub of acatheter is disposed. The apparatus includes a body, a coupling arrangedto connect the body to the hub, the coupling having an opening forreceiving the hub, a cleaning cap coupled to the body, and an actuatordisposed within the body for rotating and translating the cap relativeto the hub. The hub is snapped into the opening. When the hub is snappedinto the opening, the hub does not rotate or translate relative to thecoupling.

According to yet another embodiment, a cleaning solution fordisinfecting surfaces contaminated with biological material is disposed.The solution includes a mixture of isopropyl alcohol, chlorhexidinegluconate and hydrogen peroxide.

According to still another embodiment, a cleaning cap constructed andarranged for use with cleaning a hub of a catheter is disclosed. Thecleaning cap contains at least one of a disinfecting substance and anantiseptic fluid.

According to another embodiment, charging station for use with a devicefor cleaning a catheter hub is disclosed. The charging station includesa housing and a port disposed in the housing for receiving the device.The charging station is arranged to load an unused cap into a cap holderof the device.

According to another embodiment, a method of cleaning a hub of acatheter with an automated hub cleaning device is disclosed. Theautomated hub cleaning device includes a holder to engage the hub, acleaning cap to clean the hub and a motor to move the cap and theholder. The method includes engaging the automated hub cleaning devicewith the hub, entering a hub cleaning mode whereby the automated hubcleaning device automatically moves the cap relative to the hub toengage the cap with the hub and thereafter moving the cleaning caprelative to the hub to clean the hub, entering a hub drying mode wherebythe automated hub cleaning device automatically disengages the cleaningcap from the hub and the hub remains engaged with the holder for apredetermined drying time, and entering a hub presentation mode wherebythe automated hub cleaning device automatically moves the hub to aposition whereby the hub can be one of removed from the holder oraccessed while attached to the device.

According to still another embodiment, a method of modifying a standardcatheter hub is disclosed. The method includes at least one ofchemically changing a surface of the hub, chemically coating the surfaceof the hub with a super slippery thin films and physically changing themorphology of the surface of the hub.

It should be appreciated that the foregoing concepts, and additionalconcepts discussed below, may be arranged in any suitable combination,as the present disclosure is not limited in this respect.

The foregoing and other aspects, embodiments, and features of thepresent teachings can be more fully understood from the followingdescription in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. In the drawings:

FIG. 1A is a perspective view of a cleaning device disengaged from acatheter hub according to one embodiment;

FIG. 1B is a perspective view of the cleaning device of FIG. 1A;

FIG. 2 is a perspective view of the cleaning device of FIG. 1A with thedevice engaged with the hub;

FIG. 3 is a perspective phantom view of a cleaning device according toone embodiment;

FIG. 4A is a perspective view of a portion of the cleaning device ofFIG. 3 disengaged from a hub;

FIG. 4B is a perspective view of the cleaning device of FIG. 3 engagedwith a hub;

FIG. 5A is a perspective view of a cleaning cap for use with a cleaningdevice according to one embodiment;

FIG. 5B is a top view of the cleaning cap of FIG. 5A;

FIG. 5C is a perspective view of an exemplary catheter hub according toone embodiment;

FIG. 5D is a side view of the cleaning cap of FIG. 5A shown in partialcutaway engaged with the hub of FIG. 5C according to one embodiment;

FIG. 5E are side views of the cleaning cap of FIG. 5A shown in partialcutaway engaged with the hub of FIG. 5C according to another embodiment;

FIG. 6A is a perspective view of a cleaning cap shown in partial cutawayaccording to another embodiment;

FIG. 6B is a perspective view of a catheter hub;

FIG. 6C is a side view of the cleaning cap of FIG. 6A shown in phantomengaged with the hub of FIG. 6B;

FIG. 7A is a perspective view of a cleaning cap shown in partial cutawayaccording to still another embodiment;

FIG. 7B is a side view of the cleaning cap of FIG. 7A shown in partialcutaway engaged with a hub;

FIG. 8 is a perspective view of a cleaning cap according to anotherembodiment;

FIG. 9A is a perspective view of a cleaning device according to oneembodiment;

FIG. 9B is a perspective view of a cleaning device according to anotherembodiment; and

FIG. 10 is a perspective view of a multi-pack cartridge of cleaning capsaccording to one embodiment;

FIGS. 11 and 12 are side views of the cleaning device according toanother embodiment;

FIG. 13A is an exploded perspective view of a hub and clamp according toone embodiment;

FIG. 13B is a front view of the clamp of FIG. 13A;

FIGS. 14 and 15 are perspective views of a portion of the cleaningdevice of one embodiment;

FIGS. 16-25 are side views of a portion of the cleaning device of FIGS.14 and 15;

FIGS. 26-29 are perspective views of the cleaning device of FIGS. 14 and15;

FIGS. 30-32 are side views of a portion of the cleaning device of FIGS.14 and 15;

FIG. 33 is a perspective view of the cleaning cap according to oneembodiment;

FIG. 34 is a top view of the cleaning cap of FIG. 33;

FIG. 35 is a perspective view of the cleaning cap without a foam/clothlayer;

FIG. 36 is a rear perspective view of the cleaning cap of FIG. 33;

FIG. 37 is a rear perspective view of the cleaning cap according toanother embodiment;

FIG. 38 is a cross-section view of the hub and cap engagement accordingto one embodiment;

FIG. 39 is a geometric feature of a holding element;

FIGS. 40A-40C are views of a cap according to another embodiment;

FIG. 41 is a perspective view of the cap of FIG. 40A including the foam;

FIG. 42 is a cross-section view of the hub and cap engagement accordingto one embodiment;

FIG. 43 is a perspective view of the cap according to anotherembodiment;

FIG. 44 is a perspective view of the hub according to anotherembodiment;

FIG. 45A is a perspective view of a clamp according to anotherembodiment;

FIG. 45B is a perspective view of the hub of FIG. 44 held in the clampof FIG. 45A;

FIG. 46 is a perspective view of the hub according to anotherembodiment;

FIG. 47A is a perspective view of a clamp according to anotherembodiment;

FIG. 47B is a perspective view of the hub of FIG. 46 held in the clampof FIG. 47A;

FIG. 48 is a perspective view of the hub according to anotherembodiment;

FIG. 49A is a perspective view of a clamp according to anotherembodiment;

FIG. 49B is a perspective view of the hub of FIG. 48 held in the clampof FIG. 49A;

FIG. 50 is a perspective view of a charging station according to oneembodiment;

FIG. 51 is a perspective view of the charging station of FIG. 50 shownin partial phantom;

FIG. 52 is a perspective view of the charging station of FIG. 51 with anattached cleaning device;

FIG. 53 is a perspective view of a portion of the charging station ofFIG. 51;

FIGS. 54A-54D are perspective views of portions of the charging stationwith an attached cleaning device;

FIG. 55A-55C are perspective views of a portion of the charging station;

FIG. 56 is a chart showing various foam types according to variousembodiments;

FIG. 57 is a perspective view of one embodiment of a alcolgel foam;

FIG. 58 is a perspective view of a cleaning device according to anotherembodiment; and

FIGS. 59-60 are side views of a portion of the cleaning device of FIGS.14 and 15.

DETAILED DESCRIPTION OF INVENTION

Central line associated bloodstream infections (“CLABSIs”) are a serioushealthcare problem in the United States, having a major clinical andeconomic effect on critically ill patients. Needleless central venouscatheter (“CVC”) connectors (also known as “NCs”) are the interface bywhich equipment containing fluid to be injected into the bloodstream(e.g. syringes for bolusing medications or flushes, or tubing connectingsuch a syringe or bag using a pump) is connected to CVC ports.

Alternatively, blood can be withdrawn from a patient through a CVCutilizing a NC—this process includes three (3) syringe changes (one toremove a waste amount of blood, a second to collect the sample, and afinal one to flush fluid back into the CVC), and presents a significantrisk for catheter contamination. Although these steps are commonplace inthe use of CVCs, they are a primary mechanism by which microorganismscontaminate CVCs and cause CLABSIs.

Traditionally, CVC hubs are sterilized according to specific guidelinespublished by the Centers for Disease Control and Prevention (“CDC”).Such guidelines require that the visible areas of the cap and hub beswabbed with an antiseptic wipe, that the hub be disinfected by rubbingand scrubbing with a second antiseptic wipe (e.g., by generatingfriction by scrubbing the antiseptic wipe in a twisting motion over thethreads and tip of the hub), and that the hub be allowed to dry. As willbe appreciated, CVC hubs may not have threads in some types, and, thus,scrubbing of the side surface and tip surface may be necessary. Althoughthis approach may reduce the number of catheter-related bloodstreaminfections, there may be discrepancies between the CDC guidelines andactual practice due to inconsistent forces and duration used in manualswabbing, process fatigue (e.g., non-compliance with recommendedpractice due to competing factors, such as workload and emergent patientconditions), and frank human error (e.g., contamination aftersterilization). Various devices have been developed to improve manualcleansing of NCs. One example is a scrubbing cap with a rigid plasticbody and a filler having antiseptic-impregnated foam fingers. This capis manually twisted while maintaining a contact pressure with the hub.Another example is a cap which allows for passive disinfecting while thehub is capped. Motorized devices also have been developed, which allowfor powered rotation of a cleaning head or scrub brush with respect tothe hub. Ultraviolet light has been described as a bactericidalmechanism, but in isolation, such a technique does not allow for themechanical removal of debris and blood from the NC, an important benefitof mechanical decontamination of NCs.

According to one aspect, an apparatus for cleaning a CVC port such as aneedleless catheter hub is disclosed. For purposes herein, cleaning mayinclude scrubbing, disinfecting, decontaminating, cleansing, swabbing,and/or sterilizing. The device also may be used on any ‘female’ luerconnector, including the hub of the CVC itself, for instances in whichthe NC is being replaced (e.g., for routine tubing and NC changes or forinability to withdraw blood through an in situ NC). In some embodiments,the apparatus is a hand-held device that has a body, an attachmentmechanism for connecting the body to the hub, a cleaning cap, and anassembly within the body for rotating and translating the cap relativeto the hub. In some embodiments, the assembly is configured to move thecap linearly back and forth and also to rotate the cap clockwise and/orcounterclockwise to clean the sides and tip of the hub. In theseembodiments, the apparatus standardizes the cleaning of the device(e.g., swabbing and scrubbing) by consistently and efficientlyperforming a cleaning protocol. For example, in some embodiments, thedevice may be locked onto the hub until the cleaning protocol iscomplete, standardizing the force and duration of cleaning, as well asthe volume of chlorhexidine and alcohol used to clean; this ensuresperfect compliance with recommended practice and removes variability inpractice. As will be appreciated, in some embodiments, this may allow aclinician to attach the device to the hub, activate the device forcleaning, and walk away and tend to another patient while the hub isbeing cleaned. It should be appreciated that a clinician may be adoctor, a nurse, a technician, a medical assistant or other medicalprofessional responsible for administering and cleaning NC hubs. In someembodiments, the device may have a visual or audible indication to alertthe clinician that the cleaning protocol has been completed, thusallowing the apparatus to be unlocked and removed from the hub. Theapparatus also may include a fan or compressed, sterile gas to dry thehub after being cleaned. In some embodiments, fans, compressed air,filtered air or heat (e.g., light) may be used to dry a cleaningsolution (e.g., chlorhexidine) from the NC following scrubbing. In otherembodiments, a vacuum may be applied to the sealed cleaning compartmentto allow for an accelerated evaporation without exposure to thesurrounding air. Light also may be used to slightly heat the cap andcause evaporation. As will be appreciated, expediting the drying processmay shorten the overall time for cleaning and may improve the usabilityof the device (total cleansing time, at times up to 60 seconds usingmanual cleansing, is a major barrier to compliance with this practice).In some embodiments, the device includes a charging station. In theseembodiments, the apparatus may minimize or even eliminate potentialre-contamination of the hub.

According to another aspect, a cleaning cap for cleaning a NC isdisclosed. In some embodiments, the cap includes a body and an internalcleaning member having a shape that is configured to complement theshape of the hub. For example, the cleaning member may have cleaningthreads that correspond to the threads on the hub. In such embodiments,the cap may be rotated so that the cleaning threads engage with the hubthreads. In some embodiments, the cleaning member is also configured toflex outwardly and away from the hub so that the cleaning member withits cleaning threads can slide over and around the hub threads. In someembodiments, the cleaning member may be compressed axially and radially,which may facilitate cleaning of the hub tip and hub threads. Forexample, in some embodiments, during the cleaning procedure, sufficientfriction between the hub surface and the cleaning member is maintainedby both lateral compliance of the cap and axial actuation force. Suchcompliance between the cap and the hub may allow for thorough cleaningof both sides of the hub threads and of the hub tip. NCs contain acompressible plunger. The space between the plunger and the remaininghead of the NC (a distance of about 100 microns) makes it difficult toreach using manual cleansing or currently available devices. Thespecific design of the cleaning cap may contain a small extrusion (see,e.g., the cleaning pin 350 of FIG. 7A) which slightly depresses theplunger and cleans the aforementioned space.

In another embodiment, the handheld device may be placed partially orcompletely into a charging station. In some embodiments, this chargingstation may sterilize the device using continuous exposure toultraviolet light, exposure to heat or sonication, or by immersing itwithin a sterilizing fluid.

As shown in FIG. 1A, in one embodiment, a cleaning device 100 includes abody 102, an attachment mechanism 104, and a cap holder 106. Aspreviously described, the attachment mechanism 104 may be used to attacha CVC port such as a needleless hub 108 to the body 102 of the device100. The cap holder 106 may be configured to hold a cleaning cap 110,which, as will be described, may be translated and rotated to clean thehub 108.

As illustrated in FIG. 1A, the cap holder 106 is configured to hold thecap 110 during the cleaning protocol. In such an embodiment, a shape ofthe bottom of the cap 110 corresponds to the shape of an opening definedby the cap holder 106 such that the cap 110 may be held by or otherwiseengage with the cap holder 106. In some embodiments, the cap 110 and thecap holder 106 have a snap fit engagement. As shown in FIG. 5A, in oneembodiment, the cap 110 may have actuation pins 146 that are received bythe cap holder 106. As will be appreciated, the cap 110 may be removablyattachable to the cap holder 106, such that a new cap 110 may beinserted into the cap holder 106 prior to each cleaning.

In some embodiments, the cap 110 is manually loaded into the cap holder106 by the clinician. In other embodiments, the cap may be a part of amulti-pack cartridge 500 (see FIG. 10) and may be automatically loadedinto the cap holder 106 upon engagement between the device 100 and thecartridge (e.g., by inserting the device 100 into or against thecartridge). As will be appreciated, the multi-pack cartridge 500 may besterile and may load the cap 110 into the cap holder 106 whilemaintaining sterility. The cartridge 500 may be configured as astand-alone unit or also may be integrated into another portion of thedevice 100 (e.g., into a charging station). The device 100 also may beconfigured to install a new cleaning cap before the cleaning protocol(e.g., before an injection). As will be appreciated, the cap 110 may bedisposable.

In some embodiments, the cap 110 is manually removed from the cap holder106 after the cleaning protocol is complete and after the hub 108 hasbeen removed from the device 100. In other embodiments, the device 100may include an ejector (not shown), which is configured to eject the cap110 from the cap holder 106. In some embodiments, a clinician pushes anejection button (not shown) on the device to activate the ejector andeject the cap 110 from the cap holder 106. In other embodiments, theejector is configured to be activated automatically upon completion ofthe cleaning protocol, for example, or upon detachment of the hub 108from the device 100. In such an embodiment, the ejected cap is collectedfrom the device 100 by the clinician and is then disposed.

As shown in FIG. 1A, in some embodiments, the attachment mechanism 104includes jaws 112 a, 112 b, which define an opening 114 into which thehub 108 is insertable and held during use. Although two jaws are shownin this figure, in other embodiments the attachment mechanism mayinclude one jaw or more than two jaws for securing the hub 108 to thedevice 100. The attachment mechanism also may include elements otherthan the illustrated jaws for securing the hub 108 to the device 100. Insome embodiments, the device 100 and the attachment mechanism 104 aredesigned to prevent contamination of the hub 108 during the cleaningprocess (e.g., as might occur through handling or by placing the unit ona patient or bed or by splashing fluids).

As will be appreciated, the attachment mechanism 104 may be adjustableand configured to enable attachment of hubs 108 from differentmanufacturers. For example, when the jaws 112 a, 112 b are in an openedposition, the opening 114 may be sized to accommodate CVC hubs ofdifferent sizes. In such an embodiment, the attachment mechanism 104 isalso configured so that the jaws 112 a, 112 b may be closed to clamp orlock the different hubs 108 to the device 100. In some embodiments, theattachment mechanism 104 may be disposable or may have a specific lifetime.

In some embodiments, the NC may be customized to include grooves or evena square/rectangular segment to prevent slippage of the NC within thedevice during the scrubbing process. This would be a customized NC forthe device and may or may not be required for use.

As shown in FIGS. 1A and 1B, embodiments in which the attachmentmechanism 104 is in an opened position, the device 100 is configured toreceive the hub 108 from various directions. For example, as shown inFIG. 1A, the hub may be inserted into the opening 114 from a forward endof the device (e.g., axially), as shown by the arrow labeled H_(T). Asshown in FIG. 1B, the hub 108 also may be inserted into the opening 114from a side of the device, as shown by the arrow labeled H_(S).

In some embodiments, the device 100 includes a hub locking mechanism,which cooperates with the attachment mechanism 104 to clamp or lock thehub 108 to the device and to remain locked during the cleaning protocol.In one embodiment, as shown in FIGS. 1A and 1B, the hub lockingmechanism includes a sliding lock 116, which is positioned around anexterior surface of the body 102. In these embodiments, the lock 116moves backwards and forwards to move the jaws 112 a, 112 b into openedand closed positions, respectively. As shown in FIGS. 1A and 1B, whenthe lock 116 is in a retracted position, the jaws 112 a, 112 b are inthe opened or unlocked position.

To clamp or lock the jaws 112 a, 112 b around the hub 108, the lock 116may be moved in a forward direction, as shown by the arrow labeled L.During forward travel, the lock 116 contacts a distal end 118 a, 118 bof each jaw 112 a, 112 b, causing the jaws to move closer to one another(see, e.g., the arrows labeled J_(a) and J_(b)), and then moves on topof the jaws 112 a, 112 b. FIG. 2 illustrates an example in which thelock 116 has captured the jaws 112 a, 112 b, with the jaws 112 a, 112 bin the locked position. As shown in FIG. 1B, in some embodiments, thelock 116 includes grooves or tracks 120 into which the jaws are insertedwhen the lock 116 captures the jaws 112 a, 112 b, preventing bothrotational movement during scrubbing and axial movement during NCconnection.

In some embodiments, the device 100 is configured such that the jaws 112a, 112 b remained locked and clamped during the entire cleaningprotocol. As will be appreciated, the jaws 112 a, 112 b may be biased inthe opened position such that retraction of the lock 116 (e.g., in adirection opposite the arrow labeled L) causes the jaws 112 a, 112 b tomove away from each other (e.g., in directions opposite the arrowslabeled J_(a) and J_(b)) and return to the opened position.

As previously described, the device 100 is configured so that thecleaning cap 110 may be translated and rotated with respect to the hub108 to clean the hub 108. FIGS. 3 and 4 illustrated examples of anassembly 122 that may be used to rotate and translate the cleaning cap110. In some embodiments, as shown in FIG. 3, the assembly 122 is housedwithin the body 102 of the device 100. As shown in FIG. 4A, in oneembodiment, the assembly 122 has a first actuator 124, such as a linearactuator, which is configured to translate the cap 110 with respect tothe hub 108. As shown in FIG. 4B, an embodiment in which the cap 110 isadvanced and engaged with the hub 108, the first actuator 124 moves backand forth, as shown by the arrow labeled A₁, which moves the cap 110backwards and forwards. In another embodiment, as shown in FIG. 4A, theassembly 122 has a second actuator 126, such as a geared or motoredactuator, which is configured to rotate the cap 110 with respect to thehub 108. As shown by the arrows labeled A₂ and A₃ in FIG. 4B, the secondactuator 126 may rotate the cap 110 clockwise and counterclockwise,respectively, or may vibrate the cap. As should be appreciated, althoughlinear and gear or motored actuators are shown in these embodiments fortranslating and rotating the cap, respectively, other types of actuatorsmay be used in other embodiments. In some embodiments, the assembly mayinclude only the second actuator 126, with the translation actuationbeing performed manually.

In some embodiments, the device 100 includes a blower such as a fan forblowing air onto the hub 108 to expedite the drying of (e.g., theevaporation of) the cleaning solution used to clean the hub 108. Forpurposes herein, a cleaning solution may include a disinfectingsubstance, an antiseptic liquid or another substance suitable forcleaning the hub. As shown in FIG. 1B, in one embodiment, fans 130 a,130 b are located on each of the jaws 112 a, 112 b. As will beappreciated, the device 100 also may have only one fan or may have morethan two fans in other embodiments. In some embodiments, the fans 130 a,130 b are configured to circulate ambient air. In some embodiments,filters may be provided to purify the ambient air prior to blowing theair onto the hub 108. In other embodiments, to minimize contamination,the device 100 includes pressurized gas capsules (not shown) filled withair or carbon dioxide, for example. In these embodiments, the gas in thepressurized capsules is blown onto the hub 108 to dry the hub 108. Aswill be appreciated, the pressurized gas capsules (not shown) may beremovably attachable to the device 100 such that new capsules (notshown) may be inserted once the prior capsules are empty.

Although fans 130 a, 130 b are shown in FIG. 1A for drying the hub 108after cleaning (e.g., scrubbing) by the cleaning cap 110, it should beappreciated that other drying elements may be used in place of or inaddition to the fans 130 a, 130 b. For example, in some embodiments, thedevice 100 includes a heater for drying the cleaning solution. Thedevice also may include a vacuum that is applied to a sealed cleaningcompartment to produce accelerated evaporation without exposure to thesurrounding air. For example, in one embodiment, the lock 116 may beconfigured to create a seal around a base of the hub 108 such thatnegative pressure can develop around the hub 108. In such an embodiment,the vacuum may be applied by using fans integrated in the device as wellas by using a tube attached to a vacuum line available in the patient'shospital room.

In another embodiment, the hub 108 may be dried by using a light to heatthe cap 110 slightly and cause evaporation. For example, in oneembodiment, specially designed pigments may be incorporated into thecleaning solution (e.g., an antiseptic solution), the pigments beingable to absorb specific wavelengths to speed up the drying time.

As described above, the device 100 includes a cleaning cap 110 that istranslated and rotated with respect to the hub 108 to clean the hub. Asalso previously described, the cap 110 is configured to have compliancebetween the cap and the hub 108. In some embodiments, the shape of thecap corresponds to the shape of the hub. As shown in FIG. 5A, in oneembodiment, the cap 110 includes a cap body 132 and an internal cleaningmember 134. In some embodiments, the cap body 132 is a rigid body,although the cap body 132 may have other suitable configurations.

In some embodiments, the cleaning member 134 includes threads 136, orother helical member which correspond to the threads 138 on the hub 108(see FIG. 5C). For example, the geometry or shape of the cap threads 136may match the geometry or shape of the hub threads 138. As shown in FIG.5D, as the cap 110 is rotated, the cap threads 136 engage with the hubthreads 138 for cleaning. In some embodiments, axial and lateralcompression of the cleaning member creates friction and ensures propercleaning of the side surfaces and threads. The cap 110 may be rotateduntil the cap 110 is completely threaded onto the hub 108.

In some embodiments, the cap 110 is configured such that the cap threads136 may snap or jump over the hub threads 138 during the bidirectionallinear and rotary motion of the cap 110. In some embodiments, the cap110 itself is configured to flex outwardly (e.g., radially) and awayfrom the hub, as shown by the arrow labeled C in FIG. 5A, to allow thecap and thus cleaning member to move over the hub threads 138. In someembodiments, the cap 110 (e.g., the cap body 132 and cleaning member134) has circumferential gaps 140, which produce this radial compliance.In other embodiments, the radial compliance is accomplished by having acleaning member 134 that is elastic and itself compliant and allowscompression and expansion as the cap threads jump over the hub threads.In some embodiments, the cleaning member 134 includes a foam material,while in other embodiments the cleaning member 134 may include a fabricmaterial or another suitable material. In some embodiments, the cleaningmember 134 is soaked or saturated with a cleaning solution (e.g., adisinfecting substance or an antiseptic liquid).

In some embodiments, the cap is also configured to clean the hub tip 142(see FIG. 5C). In such embodiments, the cap 110 is configured so thatthe shape of the cap corresponds with the shape of the hub tip 142. Asshown in FIG. 5E at bottom, in some embodiments, when the cap 110 istranslated in a forward direction (e.g., when the cap 110 is threaded onthe hub or when the cap threads 136 jump over the hub threads 138), thecleaning member 134 at a bottom 139 of the cap 110 may be compressed.This compression may allow for scrubbing of the hub tip 142. Compressionof the cleaning member also may release the stored antiseptic liquidfrom the cleaning member 134.

FIG. 6A illustrates another example of the cleaning cap 210, which maybe configured for additional cleaning of the hub tip 142, namelycleaning of the valve 148 located at the hub tip 142 (see FIG. 6B). Asshown in FIG. 6A, the cleaning member 234 may include an intra-valvecleaning pin 250, which engages with the valve 148 on the hub tip 142when the cap 210 is translated in the forward direction. As illustratedin FIG. 6C, for example, the valve 148 may be pushed inwardly by thecleaning pin 250 when the hub 108 is engaged with the cap 210.

Although a cylindrical cleaning pin 250 is shown in this embodiment, inother embodiments, the pin 250 may have other geometries. For example,in another embodiment, the pin 250 may have a hexagonal cross section.As will be further appreciated, the cap 210 may have other structuresfor cleaning the valve 148 of the hub tip 142. For example, a raisedring (e.g., a ring similar in dimension to the threads 236 on thecleaning member 234) could be used to rotate in a groove surrounding thevalve 148 of the hub tip 142.

FIGS. 7A and 7B illustrate a cleaning cap 310 according to anotherembodiment. Similar to the cleaning caps previously described, thecleaning cap 310 shown in FIG. 7A may include a cap body 332 and acleaning member 334. The cleaning member also may include threads 336for engaging with the hub threads 138 and a cleaning pin 350 forengaging with the valve 148 of the hub tip 142. In the embodiment shownin FIG. 7A, the cleaning cap 310 also has threads 352 formed in the capbody 332. In some embodiment, as shown in FIG. 7B, the cap body threads352 ensure safe locking of the cap 310 to the hub threads 138 duringscrubbing. In such an embodiment, the location of the cap body threads352 corresponds with the location of the threads 336 in the cleaningmember 334.

FIG. 8 illustrates still another example of a cleaning cap 410 used toclean the hub 108. In some embodiments, as shown in FIG. 8, the capincludes an elastic body 454 that covers the circumferential gaps 440around the cap 410 (e.g., the circumferential gaps 440 in the cap body432 and in the cleaning member 434). As previously described, the capbody 432 may be a rigid structure. In some embodiments, the elastic body454 may improve compliance as well as protects the antiseptic liquidduring packaging. In some embodiments, in addition to assuringcompliance of the cap 410, the circumferential gaps 440 also act asantiseptic release pathways to ensure thorough distribution of thecleaning solution around the threaded region. In some embodiments, whenthe hub tip (not shown) is pushed against the cleaning member 434 at abottom of the cap 410, the reserved antiseptic liquid can be releasedand flow around the circumference through the pathway.

As previously described, the device 100 may be configured to run acleaning protocol to clean the hub 108. In such embodiments, the devicemay include a controller (or multiple controllers) for controlling thedevice (e.g., the actuators) and running the cleaning protocol (e.g.,the unit programming). In some embodiments, the cleaning protocolincludes a target time for scrubbing the hub 108 with the cap 110 (e.g.,by translating and rotating the cap 110 with respect to the hub 108) anda target time for drying the hub 108 (e.g., a run time of the fan afterscrubbing). The cleaning protocol also may include a target number ofrevolutions of the cap 110 (e.g., in each or both of the clockwise andcounterclockwise directions). In other embodiments, the controller isconfigured to control the cleaning and drying parameters of the device100, such as the scrubbing motion and speed or fan run times.

In some embodiments, the device 100 includes a timer (not shown). Insome embodiments, the timer is used to time the duration of scrubbing ordrying. In some embodiments, the device may be configured to turn offonce a target period of time has elapsed (e.g., the time of the cleaningprotocol). In some embodiments, this creates consistency in cleaning thehubs and also allows a clinician to attach the device to the hub andwalk away while the cleaning protocol is being completed.

In some embodiments, the device 100 is a cordless rechargeable device.In such an embodiment, the device 100 may include a rechargeable powersource (e.g., a rechargeable battery). As will be appreciated, thedevice 100 may be coupled to a charging station (see, e.g., FIG. 50),for example after the completion of the cleaning protocol, to rechargethe power source. In some embodiments, the charging station also may beconfigured to disinfect the device 100. As will be appreciated, in someembodiments, the device 100 also may plugged into a wall outlet forpower (e.g., not rechargeable).

In some embodiments, the device 100 includes wired or wireless datatransfer capabilities, which may enable unit programming, tracking ofuse and integration with ICU data systems. For example, the device 100may include integrated sensors (not shown), such as an RFID reader,which may record the patient ID and/or nurse ID for each use. In someembodiments, the device 100 also has data storage capabilities. Forexample, data may be stored on the device until the device is pluggedinto a computer or is coupled to the charging station. In otherembodiments, the data may be transmitted directly (e.g., wirelessly) toa computer after the cleaning protocol has ended. In some embodiments,this wireless confirmation of cleaning may be required to enter datainto the medication administration record, ensuring compliance withcleansing practices.

Although the embodiments shown and described include cleaning of the hubusing a cleaning cap, other cleaning techniques also may be used withthe device 100. For example, in some embodiments, the device 100 alsomay include a UV lamp, a LED light, or a steam generator for additionalor alternative cleaning. In other embodiments, the device 100 mayinclude an ultrasonic generator or other vibration source for additionalscrubbing as well as contact and penetration of the cleaning solution.In these embodiments, the ultrasonic generator or vibration source maybe located at a distal end of the second actuator 126.

In some embodiments, the device 100 includes an indicator (not shown)for alerting the clinician when the cleaning protocol has finished. Theindicator also may alert the clinician when there is an error during theuse of the device, for example an error caused by a device malfunctionor by a user mistake (e.g., an improperly installed cap 106 or hub 108).In some embodiments, the indicator (not shown) may include a visualindication such as the illumination of an LED light on the device or anaudible indication such as a beeping or buzzing sound.

In some embodiments, the device 100 includes a cleaning subassembly (notshown), that includes all of the components that contact the hub 108during the cleaning protocol, and a main body (not shown). In suchembodiments, the cleaning subassembly may include the jaws 112 and capholder. The cleaning subassembly also may include the lock 116. In oneembodiment, the main body includes the actuators, electronics andbatteries, for example, that drive the cleaning protocol. The cleaningsubassembly may be coupled to the main body via various couplingmechanisms (e.g., electrical and/or mechanical). For example, thecleaning subassembly may be coupled to the main body via linear orrotational motion using snap connectors (e.g., notched pins or slides)that may be released either by applying a force or by depressing abutton. In some embodiments, the cleaning subassembly is detachable fromthe main body of the device 100. In such embodiments, a used cleaningsubassembly may be removed from the device 100 in between patient visitsand replaced with a sterile cleaning subassembly. As will beappreciated, the cleaning subassembly also may be substantiallypermanently coupled to the main body of the device 100.

According to another embodiment, a method of using the device 100 forcleaning a CVC hub is disclosed. The method includes inserting a hubinto an opening defined by the jaws of an attachment mechanism andclamping or locking the jaws to secure the hub to the device. Forwardtravel of the slide lock 116 moves the jaws into the locked position. Aspreviously described, the locking mechanism may be configured so thatthe jaws remain locked during the entire cleaning protocol. The methodalso includes inserting a cleaning cap 110 (e.g., manually orautomatically) into the cap holder 106.

Once the cap 110 and hub 108 are attached to the device 100, theclinician may activate the device to clean the hub 108. If an erroroccurs during cleaning (e.g., the hub or cap are improperly attached orone of the actuators is unable to move the cap), the device may alertthe clinician (e.g., visually or audibly) that the cleaning was notcompleted. Otherwise, the cap 110 is advanced to engage with the hub 108and the first and second actuators translate and rotate the cap 110relative to the hub 108. After a target number of revolutions of the cap110 or after a target duration of time, the cap 110 is retracted and thefans, or other device, dry the cleaning solution applied to the hub.Once the drying has finished (e.g., after a target period of time), theindicator may alert the clinician that the cleaning of the hub 108 hasfinished.

Upon completion of the cleaning protocol, the device 100 may be unlockedand the hub 108 may be removed. A sterile cap may be then placed on thecleaned hub. The device may also facilitate placement of a sterile capafter cleaning and injection. For example, a two-part cartridge couldinclude a cleaning cap and a sterile storage cap. Once the injectionshown in FIG. 9 is complete, the device could automate installation ofthe sterile cap.

In other embodiments, an injection may be administered at the hub. Inone embodiment, the device 100 is completely disconnected from the hubprior to the injection. In other embodiments, the device 100 isconfigured to remain attached to the hub yet be moved to allow theinjection. As shown in FIG. 9A, the device 100 may include a joint 144,which facilitates administration of the injection (e.g., by reducing thenumber of steps) and possibly reduces the chances of contamination. Thejoint 144 may be a part of the attachment mechanism 104. In oneembodiment, the joint 144 is formed on a forward end of one of the jaws112 a, 112 b and is coupled to an arm 160 of the hub 108. The joint 144includes a hinge pin 170 a that allows the device 100 to remain attachedto the hub 108 while pivoting the device 100 away from the hub 108 andabout an axis X, which extends along the hinge pin 170 a and passesthrough the joint 144. Although only one arm 160 is shown hinged to onejaw 112 a in FIG. 9A, the hub 108 also may include two arms 160 a, 160 bthat are hinged to the two jaws 112 a, 112 b, respectively, via a hinge144 having hinge pins 170 a, 170 b, as shown in FIG. 9B. In such anembodiment, the arms 112 a, 112 b rotate about an axis Y extendingthrough the hinge pins 170 a, 170 b and between the jaws 112 a, 112 b.As will be appreciated, this pivoting may provide access to the hub forinjection, while providing a convenient and sterile method for holdingonto the hub.

FIGS. 11-32 illustrate another embodiment of a cleaning device 1001 usedto automatically or semi-automatically clean a NC hub. As with otherembodiments, the device 1001 includes an attachment mechanism, such as aclamp 1002, to attach and hold the hub (not shown) stationary withrespect to the device 1001 while being cleaned (e.g., supporting ahands-free operation), and a cap holder 1005 for holding a cleaning cap1004. In some embodiments, the cap 1004 is disposable.

As shown in FIG. 11, the attachment mechanism may include a couplingsuch as clamp (2) to hold the hub to the device. As shown in FIGS. 13Aand 13B, the clamp includes an opening 1099, into which the hub 1003 isinserted (e.g., snapped). The hub may be attached to the device by axialinsertion. In some embodiments, a cover 1022 (see FIG. 11) may beincluded in the device to protect the hub from contamination while thedevice is left on the bed. For example, the device could be left on thebed while performing the cleaning process without the risk ofcontamination. As shown in FIG. 13B, the clamp 1002 may include a slotor gap 1027 to allow the hub to being removed with an attached tubing orpermanent cap without the risk of recontamination.

The clamp 1002 may have a locking/ejecting mechanism which locks the hubin an axial direction to avoid ejection during the applied force whilethe hub being accessed. The locking/ejecting mechanism also may bedesigned to ejecting the hub after the cleaning protocol has finished.

As shown in FIG. 19, when the hub 1003 is inserted in to the opening1099, an external surface of the hub contacts an edge of the locking arm1111, causing the locking arm 111 to move in a direction towards the hub1003. A locking pin 1032 on the locking arm 1111 (see FIG. 17) will thencontact the hub 1003 (e.g., on the outer surface of the hub), thuslocking the hub to the clamp 1002 and preventing the hub from moving.The locking pin 1032 (or other suitable mechanism) may stop the hub fromaxial translation. In another embodiment, the device 1001 may includebuttons, such as button 1007, that will automatically actuate thelocking arm 1111 to move towards the hub 1003 and lock the hub 1003 tothe device 1000.

In some embodiments, once the hub 1003 has been cleaned, a clinician maymanually eject the hub 1003 from the clamp 1002 by disengaging thelocking arm 1111 from the hub 1003 The clinician also may manually ejectthe hub 1003 after the hub 1003 has first been accessed (e.g., after thehub has been pivoted away from the device to inject a medication intothe hub, as will be described). In such embodiments, as illustrated inFIG. 17, the clinician may apply slight force to the locking arm 1111 tomove the locking arm 1111 in a direction away from the hub 1003, whichdisengages the locking pin 1032 from the hub 1003. Once disengaged, thehub 1003 may be removed from the device. As will be appreciated, theclinician may manually eject the hub 1003 both in the pivoted positionas shown in FIG. 18, and when the hub 1003 is its original, startingposition (e.g., parallel to a longitudinal axis of the device, as shownin FIG. 17).

In another embodiment, the hub 1003 may be automatically ejected fromthe device 1000 (e.g. via an actuator). In embodiments in which the hubhas been accessed for use, the hub 1003 is first pivoted back to itsoriginal position. Once in that position, the device may automaticallymove the locking arm 1111 away from the hub 1003, thus disengaging thelocking pin 1032 from the hub 1003. In some embodiments, the locking arm1111 is disengaged from the hub 1003 via release pins 1023 (see FIG.27), which contact the locking arm and move the locking arm 1111 in adirection away from the hub 1003. In some embodiments, the automaticejection process is started by pressing a button 1007 or several buttons1007 at the same time to move the locking arm 1111 away from the hub1008.

In another embodiment, movement of the cover 1002 may urge the lockingarm 1111 away from the hub, thus disengaging the hub from the device. Insuch an embodiment, embodiments, the device may include two pins 1023,the pins being positioned so as to carefully avoid the pivotingmechanism. During the pivoting-to-origin process, the pins 1023 areengaged with the wings 1034 on the locking arm 1111 and pushes the hub1003 out of the clamp 1002 with the force applied by the linearactuation system of the clamp's pivoting mechanism. Extended wings 1034are released from the pins 1023 after the pivoting-to-origin process iscompleted. Automatic ejecting also may be performed by an additionalmechanism, without an extra actuator and while the hub clamp 1002 isbeing pivot back to its origin.

In some embodiments, the locking arm 1111 may pivot around an axis. Thelocking arm 1111 also may be spring pushed. As will be appreciated, thelocking/ejecting mechanism may be separate from the hub attachmentmechanism. That is the locking/ejecting mechanism may not affect the hubattachment mechanism.

In some embodiments, the clamp 1002 is configured to be disposable afterbeing used for a certain period of time or after completing a certainnumber of hub cleanings. In some embodiments, the clamp 1002 can beeasily removed/installed to the stainless steel extended beams (1025) onboth sides of the distal end by snapping the clamp's snap pins into theholes inside the stainless steel beams.

In some embodiments, the device is configured to allow access to the hub1003 (see, e.g., FIG. 58) without first having to remove the hub fromthe device (e.g., without first disconnecting the hub from the clamp1002). In such an embodiment, as shown in FIG. 16, the hub is accessedby pivoting the hub and attached clamp. In other embodiments, the clampis pivoted after the cleaning process, or after the hub has beenaccessed, to allow the hub to be disconnected from the device. In suchan embodiment, as shown in FIG. 17, the clamp may be pivoted such thatthe hub is returned to its original position (e.g., parallel to thelongitudinal axis of the device). In some embodiments, the clamp can bepivoted manually. Alternately, the clamp may be pivoted automatically(e.g., as actuated after pressing one or more buttons). In theseembodiments, the clamp and hub pivot with respect about the pins 1026(e.g., snap-fit pins) and about the z-axis (see FIG. 13B).

In some embodiments, as illustrated in FIGS. 14 and 15, the pivotmechanism may be connected to and, thus, work in concert with theactuation/translation system of the device. For example, as shown inFIG. 14, the clamp 1002 may be connected to the actuation system 1024.That is, on a first end, a screw 1017 and nut 1020 are attached to arotary actuator 1008 via a set of gears 1016 and 1019, and at a secondend the screw 1017 and nut 1020 are attached to the clamp valve hingepins (1029, 1031). In such an embodiment, the pivoting mechanism may beactuated by the same motor 1008 that is used to actuate the cleaning cap(4) (e.g., to rotate and translate the cleaning cap). For example, whenthe actuator rotates the cap holder relative to the body of the device,the clamp 1002 may be pivoted with respect to the device 1001. As willbe appreciated, the pivoting mechanism also may be actuated via aseparate motor.

In some embodiments, the pivoting actuation is performed while the capholder and cap are fully retracted into the device and the gear on thelinear actuator 1016 is in contact with the cap holder gear 1019, whichis actuated by the cap rotary actuation motor 1008. The linear actuationsystem, includes a linear actuator attached to a lower distal end of thedevice. In some embodiments, the linear system is mounted to the distalend of the device. In some embodiments, the cap holder gear 1019disengages the pivoting mechanism's gear while the cap and cap holderare extended out of the device to start the process.

In some embodiments, the clamp is a universal clam and is designed tofit with commercially available needless hubs. In other embodiments, theclamp 1002 and hub 1003 are uniquely designed to engage with otheranother. For example, as shown in FIG. in some embodiments, the clamp1002 includes grooves that are specifically designed to engage withcorresponding threads or protrusions on the hub. For example, as shownin FIGS. 13A and 13B, the grooves 1029 may engage with protrusions 1029on the hub 1003 to lock the hub to the device, thus preventing hub frombeing twisted during the cleaning protocol.

According to another aspect, the device may be arranged such that thehub may be easily clamped, plugged or snapped into the clamp without theneed for locking. In other embodiments, the hub may be designed forbeing clamped into the clamp (e.g., is clamp friendly). In suchembodiments, the cap holder may include a clamp, such as clamp 1501.

As shown in FIGS. 44, 45A and 45B, for example, in one embodiment, thehub 1401 includes a hexagonal locking geometry 1402, to snap or plug thehub into a clamp 1501 which includes a corresponding hexagonal lockingreceiver 1502 to prevent the hub from being twisted. As will beappreciated, other suitably-shaped hub locking geometries, andcorresponding locking receivers, may be used. As is shown in FIG. 44,the hexagonal locking geometry 1402 of the hub is sandwiched between twohub holding geometries 1422, which, in some embodiments, are cylindricalstructures. Accordingly, as the hub is inserted into the clamp (see,e.g., along arrow 1505 of FIG. 45B) the holding geometries 1422automatically block axial movement and/or translation of the hub (i.e.,forward/backward movement of the hub relative to the clamp. The holdinggeometries 1422 also may allow in-clamp injection without pushing thehub out of the clamp.

As shown in FIGS. 45A-45B, in some embodiment, the clamp 1501 includesone or more pins 1503 that engage with or otherwise overlie the lockinggeometry 1402 to lock the hub and prevent the hub from ejecting upward.One or more release levers 1504 cooperate with the one or more pins1503, respectively, such that when the release levers 1504 are pressed,the pins retract to a non-overlying or non-engaging position so that thehub can be lifted out of the clamp (i.e., along a direction oppositeinsertion arrow 1505). As will be appreciated, the levers 1505 may bepressed after the hub has been cleaned.

As shown in FIG. 46, in another embodiment, the hub may have a hexagonalshaped circumference 1402. As with other embodiments, such a hexagonalshape may be used to lock the hub in a rotational direction. As will beappreciated, other suitable circumferences may be used. The hub also mayhave a slot or gap 1406 formed in an exterior wall (e.g., in thehexagonal shaped circumference 1402, which may be used to axially lockthe hub from axial motion and/or translation, as will be explainedbelow.

In some embodiments, as shown in FIGS. 47A and 47B, the hub is easilyplugged into the clamp by translating the hub 1401 into the clamp 1501along arrow 1505. This may temporarily lock the hub in both rotationaland axial directions without the need for any optional feature topermanently lock the hub such as a locking mechanism. As with theembodiment described above with respect to FIGS. 45A and 45B, one ormore pins 1503 that engage with or otherwise overlie the lockinggeometry 1402 to lock the hub and prevent the hub from ejecting upward.Also, as with the embodiment above, one or more release levers 1504cooperate with the one or more pins 1503, respectively, such that whenthe release levers 1504 are pressed, the pins retract to a non-overlyingor non-engaging position so that the hub can be lifted out of the clamp(i.e., along a direction opposite insertion arrow 1505). As will beappreciated, the levers 1505 may be pressed after the hub has beencleaned.

In other embodiments, as shown in FIG. 48, the hub 1401 may include oneor more pins 1410 on an exterior surface to allow rotational and axiallocking. In such embodiments, the clamp (as shown in FIG. 49A) mayinclude a corresponding locking track 1510. The locking track 1510 maybe formed in a spiral shape or in another complex curve to allow axialand radial motion to tighten the hub into the clamp. In this respect, asshown in FIG. 49B (which is a rear view of the clamp 1501 (shown inphantom) to FIG. 49A), the hub is inserted along arrow 1512 into theclamp 1501 (where pins 1410 slide in a first portion of the tracks 1510)and rotated along arrow 1514 such that the pins radially move within thesecond portion of the track 1510. In this way, the hub is substantiallyheld in the clamp. In some embodiments, the hub may be simply axiallyinserted into the clamp, with a locking mechanism that locks the hubautomatically. In other embodiments, the hub is twisted to lock the hubin the clamp. As will be appreciated, in such embodiments, the lockingmechanism may be optional.

In some embodiments as shown in FIGS. 44, 46 and 48, the hubs may beneedleless (where end 1404 lacks a needle) and instead is formed as aluer lock 1403 mechanism. The hub surface may be chemically or plasmatreated. A needleless push action valve in end 1404 also may be treated.An anti-microbial coating may be applied to avoid bacteria formation aswell as blood clot formation.

In some embodiments, the hub also may be coated with SlipperLiquid-Infused Porous Surface (“SLIPS”). As will be appreciated SLIPSmay transform the surfaces of any solid material into a microscopicallythin and ultra-smooth immobilized “sea” of lubricant. This treatment mayhelp to reduce the amount of blood and microbial agents on the hubsurface (e.g., threads that are caked with dried blood and contaminatedwith microbial agents that can lead to infection and prolongedhospitalizations) and may enhance sterilization by the device. SLIPSalso may be easily coated onto any central line hub catheter usingstandard techniques and processes.

In some embodiments, the device also has a motor 1008 that rotates thecap in a clockwise or counterclockwise direction and/or in a vibrationalmanner. The device also may include a translational actuator thattranslates the motor 1008, cap holder 1004 and cap 1005 towards the hub1008 until the device engages with the hub (e.g., via the cap holder andattachment mechanism). Once has device has finished cleaning the hub,the translational actuator may retract the cap, cap holder and motor.

In some embodiments, a single motor may perform different options, whichincludes: rotating the disinfecting cap for scrubbing, axial vibratorytranslation of the cap, pivoting mechanism is actuated with the samemotor, and the airflow for drying enhancement is created with the samemotor.

As previously described, the cap may be rotated and/or translated duringthe cleaning process. In one embodiment, as shown in FIG. 12, along atranslational axis of the device 1001 there is a translational actuationsystem that manually translates the cleaning mechanism. In someembodiments, the translational actuation system is a linear actuationsystem. The linear actuation system may be motorized and may include ascrew 1010 and nut 1015 attached to a geared motor 1012 that transformsrotation to translation. The nut may be attached to a solid body or maybe integrated in the solid body which holds the motor (8) in a cabinthat is configured to only move axially inside the solid body of thedevice 1001. The translational actuation system may vibrate or performtranslational back and forth motion or apply axial force while the cap1004 is engaged with the hub 10083 for thorough and effective cleaning.In some embodiments, the translational actuation system may disengagethe pivoting actuation system from the cap actuation motor 1008. Thetranslational actuation system may include a rack & pinion mechanism.The translational actuation system also may include a position sensor.

In some embodiments, the translational actuation system is configured tobe limited or stopped mechanical or via limit switches. Thetranslational a actuation system also may be used for ejecting the hub.Additionally, the translational actuation system may be used forpivoting actuation.

In some embodiments, the translational speed can be controlled andadjusted. In some embodiments, the translational actuation system androtational actuation may work simultaneously to move the cap holderand/or cap during the cleaning process.

In some embodiments, control of the device may be performed via aprogrammable control board (14). The cleaning parameters may beadjustable based on different applications.

In some embodiments, during and after the cleaning process, a colorvarying LED may indicate the status. In some embodiments, a buzzer orspeaker may create sound to indicate the start of the process, the endof the process or may send important messages such as battery low orcleaning failure.

In some embodiment, one or more batteries may be integrated into thedevice for cordless application. The device could be charged throughwireless induction as well as electrical contact. The charging stationis designed to allow charging of the device while it is not being used,as well as in some embodiments, loading the new disposable caps ordisposing the used caps. In one embodiment, the device (1) may include arail or fitting structure (222) to allow easy attachment to the chargingstation and precise positioning on the station. The fitting structuremay be locked into the charging station as soon as the handheld deviceis returned to the station and sensed.

In some embodiments, the device includes one or more sensors. In someembodiments, the device has a number of sensors to control the cleaningand other processes, such as, for example, sensors to feedback therotational speed, count the number of rotations, limit switches,position sensor, etc. In some embodiments, a limit switch may beemployed to indicate the pivoting limit. A limit switch may be used toindicate the pivoting-to-origin limit. In other embodiments, a limitswitch is employed to indicate the cap/cap holder/translational axisextension limit. A limit switch also may be used to indicate theretraction of cap/cap holder/translational axis. As will be appreciated,the limit switch can be optical, mechanical, inductive, or capacitive.Other suitable limited switches also may be used. In some embodiments,the translational position is measured via a distance and/or positionsensor. The rotational speed of the cap actuation system may be measuredby an encoder, optical sensor, induction sensor, mechanical sensor, oranother suitable sensor. In other embodiments, two or more opticalsensors are used in the device to allow counting the number of turns,measuring the speed, or positioning the cap holder prior to theautomatic loading.

In some embodiments, the cap engages with the cap holder 1005, whichlocks the cap 1004 in rotational directions and free axial translation.In one embodiment, the cap may include a cavity, such as a hexagonalshaped cavity, to lock the cap to the cap holder.

The cap holder may have a holding mechanism with an opening to allowside load as well as axial loading. The cap holding mechanism may lockthe disposable cap on rotational directions. The cap holding mechanismalso may include complaint mechanism/s to hold the cap safely in place.In one embodiment, the cap holding mechanism is designed to allow easymanual loading of the disposable caps. The cap holding mechanism mayallow automatic loading of caps. The cap holding mechanism also mayinclude a reference structures, a body, and/or components that triggersensors, such as a rotational speed, counting or positioning sensor.

The cap-holding mechanism may include a locking mechanism toautomatically lock the cap. The cap holding mechanism may include acompliant mechanism or a spring loaded or pushed mechanism to enhancethe process. As will be appreciated, the cap holding mechanism may varybased on the cap design and can be disposed or replaced in the certaintime period.

FIGS. 33-39 illustrate various embodiments of a manual cap. Asillustrated in these figures, the plastic or polymer version includes asealed scrubbing chamber 1202 which is attached to a handling/holdingsurface 1201. Two threaded compliant member 1203 are located inside thesealed chamber. A single/multi pieces of foams 1204 are inserted intothe sealed chamber and are soaked in disinfection solution. In oneembodiment, the threaded compliant members 1203 are covered with a thinlayer of cloth/foam into which a disinfection solution is impregnated.As shown in FIG. 35B, the cap may include is a track 1206 to allow thecap to be sorted or guided in a cartridge package.

As shown in FIG. 36, in one embodiment, the end of the cap adjacent tothe holding surface 1201 includes an extra sealed cavity with a foam1207. This sealed cavity 1207 may be impregnated with a disinfectionsolution or an anti-microbial, non-stick coating such as SLIP for afteraccess blood splash cleaning and/or have an anti-microbial, non-stickcoating to reduce the surface energy and kill the infectious factors aswell as reduce the risk of blood clot formation for easy cleaning forthe next access. The same feature might be used as a standalone coatingcap for infection reduction, anti-microbial, clot resistant hub coatingpurposes.

In another embodiment, as shown in FIG. 37, the other side of the capmight be used as a permanent covering/disinfecting cap for after accessuse. As shown in FIG. 37, there is an extra sealed cavity which is Luerthreaded 1209 to be tightened on the hub thread and may include asealing ring 1210, which protects the cap from getting dried in longtime. Both side cavities are sealed in packaging process using removablesealing film.

In still another embodiment, a rubbery or elastic sealant (similar tothe sealing ring 1210) may be employed at the distal end of the sealedscrubbing cavity 1202 (see FIG. 36) to seal the cap cavity while fullylocked at the hub prior to the threshold of snapping action and use thesame cavity for permanent sealing.

In some embodiments, the cap is a manual cap that may include all thefeatures available in the motor actuated disposable caps or the exactsame cap being used for manual application. The specially designedmanual cap is designed based on a snapping threaded features, whichallows locking into the Hub threads and then jumping or snapping overthe threads when the cap is twisted, thus, thoroughly cleaning the hubtip as well as the grooves with high friction. Using the threadeddesign, the cap is hooked to the device such that the cap will not falloff while being twisted in clock-wise (or thread locking) direction,which may make it easier to reposition the hands or rest fingers whilescrubbing/twisting is being performed.

After finishing the cleaning process, the cap may be left on the hub tocover the hub and maintain a sterile environment. For example, the capmay be left on the bed or bedside without the risk of recontaminationwhile the medication is being prepared, in emergency situations, orprior to access the hub.

In some embodiments, the threaded compliant member 1203 may be coveredwith a thin layer of foam/cloth which may be impregnated with alcohol.Such embodiments may allow certain/high axial force due to the pressureapplied by the thread tightening. This also may standardize the amountof friction performed by care providers.

In some embodiments, a snapping mechanism reduces the pressureperiodically to allow the tip cleaning foam to absorb the infectiousobjects from the surface of the hub's tip. In some embodiments, thesnapping mechanism creates periodical axial motion.

In some embodiments, when the cap is rotated with respect to the hub andthe threads of the cap jump or snap over the threads of the hub, the capcreates an audible or tactile alert. That is, the cap may make asnapping sound or the clinic may feel the cap jumping from over thethread. In such embodiments, the care provider may simply count thenumber of turns that he felt or heard snapping over the thread (e.g.,the sound or vibration precisely) without needing to checking the time,as is currently done. In some embodiments, the care provider may count 5turns, 10 turns, 15 turns, or another suitable number of turnssufficient to clean the hub. In some embodiments, counting the number ofturns encourages consistency in the hub cleaning process. That is, insuch embodiments, it may be easier to count the number of turns than towatch a period of time elapse on a clock.

In some embodiments, the threaded compliant member allows the mechanicalsnapping action to avoid locking and is enhanced for low torqueactuation (see FIG. 38). This is performed by the curved, beveled, orangled thread edge 1311 as well as angled/curved periphery of thecompliant threaded member 1310, which can push against the hub's end ofthread geometry 1407 and push the compliant member aside. This may allowthe threads to release and snap over the hub's luer thread and the capto automatically move back to match the threads with the hub again. Thishappens every in each rotation of the cap around the hub.

In some embodiments, the cap includes a safe chemical compound or anindicator, such as a color indicator, is included to indicate thewetness or dryness of the cap prior to the use. For example, theindicator may alert a user when the cleaning solution in the cleaningcap has dried up and, thus, the cleaning cap is not suitable for use.

In some embodiments, the manual cap may include an opening on the sideto allow fast drying.

In some embodiments, a SLIP coating may be applied for anti-microbialcoating, to reduce the surface energy and to avoid clot formation tomake the next cleaning process easier and reduce the amount of bacteriaon the hub surface.

In some embodiments, the handling/holding element 1201 may include somegeometrical features 1212 to enhance actuation and reduce the slipping.

In some embodiments, the cap is designed to be inserted into amulti-pack cartridge (see, e.g., FIGS. 10 and 53). The caps may bestacked together in numbers and in a self-sealing manner, with each capsealing the next cap in the stack/cartridge.

As shown in FIG. 42, in some embodiments, the threads of the cap may bedesigned with a curved, beveled or angled edge to avoid locking andassist a thread snapping mechanism to work with lower torque As will beappreciated, this enhancement is performed by the curved, beveled, orangled thread edge 1311 as well as angled/curved periphery of thecompliant threaded mechanism 1310 which can push against the hub's endof thread geometry 1407 and push the compliant mechanism aside andallows threads to release and snap over the hub's luer thread and thecap automatically moves back to match the threads with the hub again.This happens in each rotation of the cap around the hub. This featureassists it to flex away of the threaded hub and help low torque snappingaction. This can be adjusted and modified for different hub design tomake use of their specific geometrical embodiments. On the other handreduces the battery consumption of the handheld device.

In some embodiments, the cap creates fast axial translation (axialperiodic back and forth motion/vibration) while being rotated by only arotary actuation which eliminates the need for an axial actuator. Thisis the result of its compliant threaded feature that causes threadsnapping action and pushing the cap one thread back to match the threadstogether.

In some embodiments, two or more threaded or partially threadedcompliant cover members 1303 are used in a 180 degree positionconfiguration with two (or more) gaps 1305. An accommodating sponge orfoam 1306 may be positioned in between the two or more gaps forreserving the disinfection chemical solution and absorption of the dirtor blood clot. In some embodiments, the foam and threaded compliantmember are integrated in an embodiment which covers the foam and ensuresencapsulation or an originally sealed cavity 1301. The cap is sealed toavoid dryness and can be unsealed prior to the use. The sealed cavity1301 may be designed to be sealed with a film attached to the cavity.The film does not touching any of the foams or compliant threadedmechanism.

In some embodiments, the cap has a structure 1302 which enablesactuation. For example, the body of the cap may have a hexagonal shape1302, which enables loading and/or unloading actions to be performedboth manual or automatically. Color chemical indicators may be used tosense the wetness of the cap prior to unsealing. A broad range ofchemicals may be used. The cap embodiment may be made of transparentmaterial to allow visual inspection of the cap state. In someembodiments, the cap color may change in the absence of disinfectingagent.

In some embodiments, a thick foam/sponge 1306 is used in the gap forcleaning the surface of the thread and the tip as well as partiallypenetrating into the threaded grooves of the hub. A thinner layer offoam or cloth (307) or similar material may be placed over the threadedstructure 1303 and may be soaked in disinfection solution. It is meantto penetrate the grooves and deep cleaning. While the thread snaps overthe thread it also ensures thorough side cleaning with high friction.

In some embodiments, the cap design may include a structure, for examplea turbine 309, in the outer/inner body which creates air flow whilebeing rotated. This may decrease the time of drying. The airflow mightbe blowing or preferably here creating vacuum around the hub.

The cap may be designed with a compliant structure to perform cleaningin two stages: In a first stage, the cap squeezes the foam between thecap structure and the hub to release as much disinfecting solution aspossible. In the second stage, the pressure on the cap is released andthe cap's foam is expanded to absorb maximum dirt and particles from thehub surface and enhance the drying time by absorbing most of thereleased disinfection solution.

In some embodiments, the cap may include a capsule membrane which holds(encapsulates) the whole or part of the disinfection solution andreleases them under pressure after being tightened to the hub. Theencapsulated solution can be SLIP for anti-bacterial coating andnon-sticky surface coating. The cap may integrate a pin/needle shapestructure to perforate the capsule and release the chemicals. SLIPsurface treatment material might be included in the disinfectionsolution or being sprayed automatically after drying process iscomplete.

According to one embodiment, the cap may be designed to be insertedinside a cartridge system. The caps also may stacked together in numbersin a self-sealing manner and each cap seals the next cap in thestack/cartridge.

As previously described, and as shown in FIG. 52, in some embodiments,the device may be coupled to a base, such as charging station. As willbe appreciated, the charging station may be configured to charge thedevice. In some embodiments, the charging station may wirelessly chargethe device, although the device also may be charged via a wiredconnection (e.g., via a cord). For example, the charging station 1601may include conducting contact 1605 for contact charging of the device.The charging station also may include a wireless charging coil forcontactless charging. As will be appreciated, the charging station maybe installed on the bed or at a variety of bedside locations.

As shown in FIG. 51, the charging station 1601 includes a port 1604,into which a device 1609 may be plugged. As will be appreciated, theport 1604 may lock the device 1609 to the charging station 1601mechanically, by an actuator, or by magnetic force. In some embodiments,the port 1604 also may include guiding members to encourage easy andprecise coupling and decoupling of the device and charging station. Forexample, the port 1604 may include tracks that are inserted intocorresponding openings in the device 1609 when the device is coupled tothe charging station 1601.

In addition to charging the device, the charging station also may beconfigured to sterilize the device (e.g., via UV light for disinfectionpurposes), download and/or transmit data, and/or dispense a cleaningcap.

FIG. 51 shows a charging station 1601 into which disposable caps 1608have been loaded. In some embodiments, the charging station may beloaded with between 1 cap and 200 caps. In other embodiments, thecharging station may be loaded with between about 25 caps and 200 capsAs with other embodiments, in this embodiment, the caps 1608 are storedin a multipack cartridge 1606 (see FIG. 53), that is loaded into thecharging station 1601. In one embodiment, the charging station mayinclude a pin 1602, or other suitable mechanism) for precise insertionand loading of the cartridge into the charging station 1601. In such anembodiment, the cartridge may include a corresponding opening into whichthe pin 1602 is inserted.

In one example, the cartridge may have a spiral or circularconfiguration to accommodate large numbers of caps in the cartridge. Inanother example, the cartridge may have a number of caps in a stackedform for automatic loading. As will be appreciated, the caps may bedisposable.

The caps may be sealed using a ribbon (e.g., a roll or film) of analuminum or polymer film 1610. In one embodiment, the caps may arepositioned in a specific arrangement on the ribbon with a desireddistance between adjacent caps. The ribbon 1610 is wound around awinding roller 1607 inside the cartridge. As will be described, anactuated spool, actuated by a motor, may be used to unwind and move theribbon 1610 and, thus, move and position the caps inside the cartridge.As will be appreciated, with this sealing and unsealing mechanism, thecaps 1608 may be kept within the cartridge (e.g., unsealed and sanitary)until only moments before the cap is positioned in the cap holder foruse.

In some embodiments, the charging station 1601 may automatically load anew (e.g., fresh or unused) cap into the device 1609 (e.g., into the capholder). As will be appreciated, the caps also may be manually loadedonto the device. For example, a clinician may remove a cap from thecharging station and manually insert the cap into the cap holder of thedevice. In some embodiments, the charging station 1601 also may be allowautomatic unloading and/or disposing of the used (e.g., expired ordirty) caps from the device 1609. For example, in one embodiment, thecharging station includes an opening into which the dirty caps may beinserted.

An example of the loading process is illustrated in FIGS. 54A-D. As isshown, the loading process involves moving the device towards thecartridge until the cap holder 1618 is positioned adjacent to an openingin the cartridge. In some embodiments, the cap holder 1618 may bepositioned adjacent to the opening when the device is inserted into theport 1604. As is shown in FIG. 52B, after the device 1609 is insertedinto the port, the cap holder is positioned adjacent the opening bylaterally translating the port device. In some embodiments, the port maytranslate via an actuator, while in other embodiments, the port may bemanually translated by pushing the device. Next, a cap is laterallyloaded into the cap holder (see FIG. 54C). Finally, as shown in FIG.54D, once the cap has been loaded and locked in the cap holder, the portand device translate back to the original position. The device may nowbe picked up by a user and used to disinfect a hub. As will beappreciated, in embodiments in which the device and port were nottranslated (e.g., the device was simply inserted into the port for caploading), once the cap has been loaded and locked in the holder, thedevice is ready for use. In some embodiments, the device is locked intothe charging station while the cap is being loaded into the cap holder.

Although the cap is described as being laterally loaded into the capholder, it will be appreciated that other suitable arrangements may beused. For example, in one embodiment, the cap 1609 may be axially loadedinto the cap holder. In such an embodiment, the device may be moved toperform the axial loading of the cap. In still another embodiment, thecap may be picked up and inserted into the cap holder via a separateactuation system. In yet another embodiment, another feature, such as atrack 1619 on the cap (see FIG. 55A), may be used for cap handling.

An example of the lateral loading of the cap into the cap holder isillustrated in FIGS. 55A-55C. In this embodiment, as shown in FIG. 55A,the next sealed cap is kept sealed and inside the cartridge until justbefore being used (e.g., until the device is inserted into the port).Next, as shown in FIG. 55B, as the sealing ribbon 1610 is wound via theactuated spool 1603, the ribbon 1610 and cap 1608 are moved towards theopening (see arrow labeled C1). As the ribbon 1610 is moved around ledge1613 and towards the roller (see the arrow labeled C2), the cap 1608 isseparated or peeled from the ribbon 1610 and moved, onto the platform1615, for insertion into the cap holder in an unsealed form. In someembodiments, the cleaning caps may be peeled and inserted into the capholder in between about 1 and 10 seconds. In some embodiments, theunsealed cap must be used within about 2 to 5 minutes. A will beappreciated, the caps must be used before the necessary amount ofcleaning solution is dried up. As described, the cleaning cap may havean indicator to alert a clinician when an unused cleaning cap is nolonger suitable for use.

Although the caps are shown as being unsealed by peeling the caps fromthe ribbon in a lateral movement, the caps may be unsealed in othermanners. For example, the caps (608) may be unsealed by twisting oranother suitable motion that peels off the sealing. In anotherembodiment, the sealing on the cap may be a breakable membrane, which isruptured before use. In still another embodiment, the sealing is cut offby the system prior to the loading. In yet another embodiment, thecomplete spiral ribbon of caps is actuated by a motor or mechanicalactuator.

In some embodiments, the cartridge includes sensors for position sensingand/or limit switches. For example, the cartridge may have an integratedsensor to check the position of the cap. In some embodiments, thecartridge is transparent or has a transparent window or an opening toallow for a user to view that the cap is in the required position forprecise loading of the cap into the cap holder.

In some embodiments, the cartridge is disposed. In other embodiments,the cartridge may be reused. That is, disposable (or reusable) caps maybe loaded into a reusable cartridge.

In some embodiments, the charging station communicates with a controlboard through digital, serial or wireless communication techniques.

The charging station may include various sensors for position sensing,loading sensing, plugging sensing, alcohol sensing, cartridge sensing,and/or cartridge status. Other suitable sensors may be used in otherembodiments.

In one embodiment, the charging station includes a wet detection sensorto ensure that the loaded caps are not dried because of sealing problem,production and packaging issues. For example, the sensor may sense forthe presence of alcohol on the caps. In some embodiments, the wet sensormay include a vacuum pump that sucks the air through an optical,chemical, or capacitance sensor to detect for the presence of moisture(e.g., the presence of alcohol). The wet sensor also may include a colorsensor that detects the presence of moisture by checking for a change inthe color of the cap, foam and/or sealing.

The charging station also may include some optical and vocal indicatorsand alarms to inform the system status, failure, and/or cap dry-out,although other events may trigger the alarm. In some embodiments, thecharging station includes a log file to record the system status anduse. The charging station also may include an RFID tag (or other tag)reader/writer to read the type of caps, cartridge, and/or programming.

In some embodiments, the charging station may include a programmabletiming process to dismiss the cap that is loaded and has not been usedfor certain period of time. In such embodiments, the cartridge mayinclude a code or other type of indicia (e.g., RFID, color, serial,barcode, or security tag) that communicates with the charging station tochange the program for specific model of cap, check the expiry date, orindicate the number of tag being used and the remains.

In some embodiments, the charging station may be arranged to disinfectthe device, caps, and/or charring station. For example, the chargingstation may include a UV light for disinfection purposes.

As will be appreciated, the charging station may be installed on the bedor at another suitable bedside location. The charging station also maybe installed outside of the patient's room (e.g., at a nurses station).The charging station may include a cable attached to the handheld devicein embodiments in which the device is not meant to be cordless. Thecharging station also may include a wireless charging coil for contactless charging. The charging may be performed through conducting contact.

As will be appreciated, the cleaning cap may have various differentdesigns. For example, the cap may be fitted with a variety foam, it mayprotect the hubs by encapsulating them with an alcoholic gel, it mayinclude a precast foam infused with various monomer solutions, it mayinclude multiple modes of antimicrobial activity, and/or it may be anantimicrobial cap, or may be a free radical generating cap.

In some embodiments, the cap may be fitted with a variety commerciallyavailable foams using standard techniques. Foams may be composed of avariety of different polymers including, but not limited to,polyurethanes, polyesters, polyanhydrides, polyethers, polyethylenes(linear or cross-liked), and formaldehyde-melamine-sodium bisulfitecopolymers. In some embodiments, the foams are selected based onswelling ratio (Q) and mechanical strength (i.e., shear moduli, G). Thefoam also may have a medium density (1-5 g/cm³) open-cell reticulatedstructure with pore sizes ranging from 100-1000 μm, a Q value of >400for solutions containing 70% isopropyl alcohol (IPA) and shear moduliG>1 GPa. FIG. 56 provides a list of commercially available foams thatwere soaked in 70% IPA for 24 hours and that had their swelling ratiosdetermined.

In such embodiments, cleaning of the hub may be accomplished by suturingthe foam with an alcoholic solution (e.g., 70% isoprophy alcohol (“IPA”)containing chlorohexidine (1-2 wt/vol %) before the cap is sealed.Cleaning may be initiated when the practitioner removes the seal andplaces the cap in the device. That is, the device threads the cap on thehub, which puts the hub into direct contact with the alcohol-containingfoam. The cap may be rotated around the hub at high speeds, whichsimultaneously cleans, disinfects, and dries the hub. Alternately,cleaning of the hub is accomplished by placing a sponge or a capsulecontaining a chlorohexidine alcoholic solution (70% IPA) in the bottomof the cap. In such embodiments, when the device threads the cap ontothe hub, the capsule breaks and releases the cleaning solution.

In other embodiments, alcogel caps may be used to to protect centralline hubs by encapsulating them within an elastic alcoholic gel, alsoknown as alcogels. As will be appreciated, alcogels are hydrophilicmaterials that contain low mass fractions of cross linked polymers (≤10wt %) that may retain a significant fraction of alcoholic-solutionswithin their polymer structure. The amount and type of alcoholicsolution that can be retained within these materials may be tailored bycareful selection of the monomers and cross linking agents as well astheir relative mole fractions in the final cross linked polymer. Forexample, monomers such as acrylic acid, styrene,2-acrylamido-2-methylpropane sulfuric acid (AMPS), N-isopropylacrylamide(“NIPAM”), and methacryloyloxyethyl phosphorylcholine can be crosslinked with Zn2+, N,N′-methylenebisacrylamide (“MBA”), ethylene glycoldimethacrylate (EGDMA), triethylen glycol dimethacrylate (“TEGDMA”), and1,3-di-glycerolate to yield different gels with varying alcoholabsorbing abilities. Polymerization may be facilitated viaγ-irradiation, x-ray irradiation, or chemical cross linking, which mayenable one to use fabricate caps with matching threads to the mostcommonly used hubs. In one embodiment, the alcogel is comprised ofmaterials Generally Regarded as Safe by the FDA and absorbs between50-200 g/g of 50-90 vol % ethanol or isopropyl alcohol. A representativealcogel polymerized from 2-acrylamido-2-methylpropane sulfuric acid withPEGDMA as a crosslinker is shown in FIG. 57.

Cleaning with the alcogel cap may be achieved by removing the seal andthreading the device onto the desired hub. In one example, disinfectionoccurs through the direct surface contact between the alcogel and theHub, which provides constant exposure to a 70% IPA solution. As will beappreciated, the threading mechanism enables disinfection of thethreads, an area that is notoriously difficult to clean with the currentstandard of care.

In other embodiments, a hydrogel-foam hybrid caps may be use. In someembodiments, precast foams with desired mechanical properties can beinfused with various monomer solutions and subsequently cross linked toyield an interpenetrating network with improved mechanical and chemicalproperties. For example, malemine foams have a large swelling ratio(Q=724) but very poor mechanical properties. To enhance the mechanicalproperties, these foams can be infused with elastic monomers such asacrylic acid and PEGDMA. By tailoring the monomer weight percents andthe degree of crosslinking, these foams may be transformed into highlyelastic hybrids materials.

In another embodiment, an antimicrobial cap may be used. As will beappreciated, antimicrobial caps may be hydrogel-based caps that containantimicrobial agents and nanoparticles embedded within their structure.Hydrogels may be fabricated using water-soluble monomers that are crosslinked using either γ-irradiation, x-ray irradiation, UV or chemicalreagents. Monomers may be selected from a broad array of materials (i.e.polyethylene glycol, polyacrylic acid, polyacrylamide, polyvinylalcohol, N-(2-Hydroxypropyl) methacrylamide (HPMA), Xanthin Gum,pectins, chitosan, dextran, carrageenan, guar gum, cellulose ethers,hyaluronic acid, albumin, starch and starch based derivatives, amongothers). Antimicrobial agents may include chlorohexidine, peptides(chosen from the Antimicrobial Peptide Database, APD; contains 2600peptides), or nanoparticles. These reagents may be easily modified tocontain a cross-linkable group using standard techniques andincorporated into the hydrogel using the before-mentioned conjugationtechniques. The material properties of the gels (i.e. elasticity,rigidity, compressibility, etc.) may be tailored by careful selection ofthe monomers and cross linking agents as well as their relative molefractions for a given formulation. Similar to alcogels, these systemsmay enable fabrication of caps with matching threads to the mostcommonly sold hub devices.

Cleaning with the antimicrobial cap may be achieved by removing the sealand threading the device onto the desired hub. In some embodiments,disinfection occurs through the direct surface contact between theantimicrobial peptides and nanoparticles and the hub, which providesconstant exposure to a antimicrobial agents. In some embodiments, theunique threading mechanism enables disinfection of the threads, an areathat is notoriously difficult to clean with the current standard ofcare.

In still another embodiment, an hybrid cleaning cap may be used. As willbe appreciated, alcohol based disinfectants work by denaturation ofproteins, osmolarity works by rupturing/collapsing the cell membrane,antimicrobial agents disrupt the cell membrane, and peroxides generatefree radicals which rupture the cell membrane and damage the bacteria'scellular machinery. In some embodiment, a hybrid cap combines multiplemodes of antimicrobial activity into a single device to provide enhancedmicrobial activity. These Possible configurations may include: (1) analcogel containing chlorohexidine (1-5 wt %) (Hypotonicsolution+antimicrobial agent); (2): a hydrogel containing a hypertonichydrogen peroxide solution (359 g/L NaCl, 3% H2O2). (Hypertonicsolution+Radicals); (3) a hydrogel containing hydrogen peroxide solution(3% H2O2) (Hypotonic solution+Radicals); (4) a hydrogel containinghydrogen peroxide solution and poly-L-lysine (Hypotonicsolution+Radicals+Antimicrobial Agents); and (5) an alcogel containingHydrogen Peroxide and chlorohexidene (Alcohol+Radicals+AntimicrobialAgents). In some embodiments, a cleaning solution may include acombination of between about 0.5-5% chlorhexidine gluconate by volume,70-90% isopropyl alcohol by volume, and between about 5 and 20% hydrogenperoxide by volume.

In yet another embodiment, a free radical generating cap may be used. Aswill be appreciated, UV radiation is one of the most effectiveantimicrobial therapies because it can generate larger concentrations offree radicals, which rupture the cell membrane and damage the bacteria'scellular machinery. In some embodiment, a radical cap aims to imitatethe radical generating capabilities of UV light with chemical reagents.Such radical caps may require two (or more) reagents to generate thefree radicals, an initiator and an accelerant. In some embodiments, toenable the prolonged generation of radical species one reagent isdispersed within the foam/hydrogel (Reagent A) while the other reagentis encapsulated within a microbead (Reagent B). The microbead may befabricated using the same water-soluble polymer described above andusing a variety of techniques, such as reverse emulsion polymerization.The material properties of the beads also may be tailored such that thepressure applied during the cleaning process releases Reagent B from themicrobead and triggers radical generation. There are severalcombinations of chemicals that may be used to generate free radicals.Possible combinations may include (1) APS/TEMED; and (2) NOS/L-arginine.

As will be appreciated, although embodiments have been shown anddescribed for modifying cleaning caps (e.g., applying various foams,hydrogels, and alcogels to the interior surface of the cleaning cap), itshould be appreciated that the hubs also may be modified. Allcommercially available catheter hubs are fabricated from thermoplasticsthat have smooth surfaces and no chemical functionality. The adhesion ofbodily fluids and bacteria to their surfaces is a function of the hubssurface chemistry. In some embodiments, the hub surface is renderedsuperhydrophobic to minimize unwanted adhesion. For example, surfacemodified hubs are fabricated by exposure to oxygen plasma followed bytreatment with functionalized perfluorocarbon-based silanes, whichrenders the surface hydrophobic. Further treatment with liquid basedperfluorocarbons permenantly immobilizes a thin film on the hub surfacethat renders the hub superhydrophobic and facilities self-cleaning (i.e.prevents adhesion of blood and bacteria). In other embodiments, themicrostructure of the hub surface can be physically altered to renderthe surface superhydrophobic. For example, lasers can be used to createetched groves with controlled spacings and depths on the hub surface,which allows one to control the wettability and hence the hydrophobicityof the surface.

In yet other embodiments, the cleaning of surface modified hubs maybeaccomplished using any of the cap designs described above. In addition,the super lubricating layer may be continually replenished in thesesystems by encapsulation of the oil within said foam, hydrogel, oralcogel. In some embodiments, the advantage of this approach may be thatthe hub is cleaned and simultaneously coated with the lubricant, whichaids in preventing adhesion of blood and bacteria. In some embodiments,the combination of the super lubricating film and the unique cleaningmechanisms may greatly reduce the risk of infection during long termuse.

As will be appreciated, manufacturing processes that enable productionof caps or hubs including blow molding, injection molding, screwextrusion, die extrusion, calendering, compression molding, rotationalmolding, thermoforming, and power injection molding.

While the present teachings have been described in conjunction withvarious embodiments and examples, it is not intended that the presentteachings be limited to such embodiments or examples. On the contrary,the present teachings encompass various alternatives, modifications, andequivalents, as will be appreciated by those of skill in the art.Accordingly, the foregoing description and drawings are by way ofexample only.

The invention claimed is:
 1. A cleaning cap for cleaning a needlelesshub of a catheter, the cap comprising: a cap body defining a cavity andincluding one or more gaps disposed about a circumference of the capbody, the one or more gaps extending axially from a first end of the capbody; and a cleaning member disposed within the cavity, the cleaningmember having cleaning threads that engage with external threads of thehub; wherein the one or more gaps are configured to allow outward radialflexing of the cleaning member.
 2. The cleaning cap of claim 1, whereinthe cleaning member includes a foam material.
 3. The cleaning cap ofclaim 1, wherein the cleaning member includes a fabric material.
 4. Thecleaning cap of claim 1, wherein the cleaning member includes at leastone of a disinfecting substance and an antiseptic fluid.
 5. The cleaningcap of claim 1, wherein the cleaning member is configured to flexradially away from and slide over the external threads of the hub suchthat the cleaning threads are at least one of slidable, snappable, orjumpable over the external threads of the hub.
 6. The cleaning cap ofclaim 1, further comprising actuation pins that extend from a bottomsurface of the cap body, the actuation pins configured to engage with acleaning apparatus.
 7. The cleaning cap of claim 1, wherein the cleaningmember comprises a cleaning pin configured for intra-valvular cleaningof a valve of a tip of the hub.
 8. The cleaning cap of claim 7, whereinthe cleaning pin has a cylindrical shape.
 9. The cleaning cap of claim1, wherein the cleaning member comprises at least one of a foam, ahydrogel and an alcogel.
 10. The cleaning cap of claim 9, where the atleast one of the foam, the hydrogel and the alcogel encapsulates atleast one of an alcoholic solution, a radical generating solution,antimicrobial peptides, antimicrobial nanoparticles, and disinfectants.11. The cleaning cap of claim 9, wherein the at least one of the foam,the hydrogel and the alcogel encapsulates a self-cleaning solution, theself-cleaning solution having organic oils.
 12. The cleaning cap ofclaim 11, wherein after the hub is cleaned, the self-cleaning solutionis arranged to coat the hub to render it superhydrophobic.
 13. Thecleaning cap of claim 5, wherein when the threads of the cleaning memberslide, snap, or jump over the external threads of the hub, the cap makesan audible or tactile alert.
 14. The cleaning cap of claim 1, whereinthe cap further comprises an indicator to indicate at least one of awetness or dryness of a cleaning solution in the cap prior to use. 15.The cleaning cap of claim 14, wherein the indicator is a color indicatorarranged to display a color when the cleaning solution in the cap isdry.
 16. The cleaning cap of claim 1, wherein the cleaning threadsinclude at least one of a curved, angled or beveled shape.
 17. Thecleaning cap of claim 1, further comprising a cloth disposed over thecleaning threads.
 18. The cleaning cap of claim 2, wherein the foamcontains at least one of a cleaning solution and a membrane capsule. 19.The cleaning cap of claim 2, wherein the foam is disposed along at leasta portion of the cavity.
 20. The cleaning cap of claim 1, furthercomprising a seal to cover the cavity.
 21. The cleaning cap of claim 1,wherein an exterior surface of the cap body includes at least one of ahandle or holding feature for manual use.
 22. The cleaning cap of claim4, wherein the at least one of the disinfecting substance and theantiseptic fluid comprises at least one of aqueous solutions of ethanol,isopropyl alcohol, and hydrogen peroxide, antimicrobial peptides,hypotonic or hypertonic salt solutions, and nanoparticles.
 23. Thecleaning cap of claim 1, the cleaning cap containing at least one of adisinfecting substance and an antiseptic fluid comprised of an aqueousalcoholic solution, radical generating solutions, antimicrobial agents,and other disinfectants, and any combination thereof.
 24. The cleaningcap of claim 23, wherein the antimicrobial agents include 0-10%chlorohexidine, antimicrobial peptides, and nanoparticles.
 25. Thecleaning cap of claim 23, comprising 70% IPA, 3% H₂O₂, and 5%chlorohexidine.